Patiromer

What is patiromer?

Patiromer is a prescription medicine that is used to treat high potassium levels.

Description

Veltassa is a powder for suspension in water for oral administration. The active ingredient is patiromer sorbitex calcium which consists of the active moiety, patiromer, a non-absorbed potassium-binding polymer, and a calcium-sorbitol counterion. Each gram of patiromer is equivalent to a nominal amount of 2 grams of patiromer sorbitex calcium.

The chemical name for patiromer sorbitex calcium is cross-linked polymer of calcium 2-fluoroprop-2-enoate with diethenylbenzene and octa-1,7-diene, combination with D-glucitol.

Patiromer sorbitex calcium is an amorphous, free-flowing powder that is composed of individual spherical beads. Patiromer sorbitex calcium is insoluble in solvents such as water, 0.1 M HCl, n-heptane and methanol. The chemical structure of patiromer sorbitex calcium is presented in Figure 1.

Figure 1: Chemical Structure of Patiromer Sorbitex Calcium

Each packet of Veltassa contains 8.4 grams, 16.8 grams or 25.2 grams of patiromer, the active moiety. The inactive ingredient is xanthan gum.

Mechanism of Action

Veltassa is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol counterion.

Veltassa increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels.

Before taking patiromer, tell your doctor:

• If you are allergic to patiromer; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Bowel block, constipation, or problems having a bowel movement.

This is not a list of all drugs or health problems that interact with patiromer.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take patiromer with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take patiromer?

• Tell all of your health care providers that you take patiromer. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Follow the diet plan that your doctor told you about.
• This medicine prevents many other drugs taken by mouth from getting into the body. If you take other drugs by mouth, take them at least 3 hours before or 3 hours after patiromer. If you are not able to do this, talk with your doctor.
• If you are 65 or older, use patiromer with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using patiromer while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is patiromer best taken?

Use patiromer as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Do not heat or microwave.
• Do not mix patiromer in warm or hot drinks.
• Do not take dry powder.
• Mix powder with water only as you have been told.
• Do not mix with other liquids.
• Measure 1/3 cup (80 mL) of water. Pour half of the water into a glass, mix in the powder and stir. Add the rest of the water and stir well. The powder will not dissolve. The mixture will look cloudy. You can add more water if the mixture is too thick.
• After mixing, take your dose right away. Do not store for future use.
• Rinse cup with more water and drink. Repeat as needed to make sure the entire dose is taken.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of patiromer that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.

What are some other side effects of patiromer?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation.
• Diarrhea.
• Upset stomach.
• Belly pain.
• Gas.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out patiromer?

• Store in a refrigerator. Do not freeze.
• You may also store patiromer at room temperature. If stored at room temperature, throw away any part not used after 3 months.
• Protect from heat.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 8.4 G PACKET CARTON

PRINCIPAL DISPLAY PANEL – 16.8 G PACKET CARTON

• 30 packets
  NDC 53436-168-30
• Veltassa®
  (patiromer)
• For Oral Suspension
• www.veltassa.com
• Each packet contains 16.8 grams of patiromer.
  Dispense as 1 box; 30-day supply.
• Rx only
• 16.8 g

PRINCIPAL DISPLAY PANEL – 25.2 G PACKET CARTON

• 30 packets
  NDC 53436-252-30
• Veltassa®
  (patiromer)
• For Oral Suspension
• www.veltassa.com
• Each packet contains 25.2 grams of patiromer.
  Dispense as 1 box; 30-day supply.
• Rx only
• 25.2 g

SRC: NLM .